Korean companies win first round of Entresto patent suit

what’s next?

10 companies including Hanmi to secure first generic exclusivity… Daewoong may be added to the list of generic companies

Risks such as Novartis’s appeal, overcoming non-listed and newly listed patents, patent infringement suits, etc. remain for generic release

Pic of Entresto.

The first patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) ended with the victory of the Korean generic companies.

 

The exclusive market approval (first generic exclusivity) that received attention is expected to be granted to 10 companies including Hanmi Pharmaceuticals, with the possibility of Daewoong Pharmaceuticals additionally receiving generic exclusivity.

 

However, the industry analysis is that there remain risks for the generic companies' early release of Entresto latecomers as the original company Novartis has announced its plan to appeal, and separate legal disputes such as patent infringement suits and injunction applications are still ongoing.

 

◆10 companies overcome the fourfold patent hurdle…meets first generic exclusivity requirements According to industry sources on the 28th, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the 2 trials to confirm the passive scope of rights of Entresto’s composition patent that was filed by 9 companies including Chong Kun Dang against Novartis.

 

Nine generic companies including Chong Kun Dang, YooYoung Pharmaceutical, Hanlim Pharm, Hana Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Elyson Pharm received the favorable ruling.

 

With the ruling, on which companies will be receiving generic exclusivity has been somewhat revealed.

 

Hanmi Pharmaceuticals was the first company to overcome all 4 of Entresto’s patents, and with the addition of the 9 companies that received the recent ruling, a total of 10 companies have now paved the way for the early release of their generics.

 

The companies have obtained the ‘first to request for trial’ requirement by filing claims from January 2021.

 

In April, the companies also applied for generic marketing authorization together and fulfilled the ‘application for first latecomer drug approval’ requirement as well.

 

By ‘winning the patent suit,’ the companies met the last requirement to receive first generic exclusivity.

 

The companies would now only need to receive official approval from the Ministry of Food and Drug Safety.

 

Also, Daewoong Pharmaceuticals may also additionally secure first generic exclusivity.

 

Daewoong Pharmaceuticals succeeded in invalidating or avoiding 3 of 4 Entresto’s patents.

 

The company is currently challenging Novartis to invalidate the last remaining patent, and if Daewoong wins the last suit, the company will also be able to satisfy all of the first generic exclusivity requirements like the other 10 companies.

 

The ruling on the trial is expected to be made within this month.

 

◆"Non-listed and newly-listed patents remain risk factors on the safe release of generics" The industry evaluates that Entresto’s patent dispute has virtually been settled with the generic companies’ win in the first trial.

 

However, there is also an analysis that risks remain for the early release of the generic companies’ generics despite the complete victory they had made in the first round.

 

The biggest risk factor is Novartis’s appeal.

 

Novartis appealed against the first trial ruling and filed a suit for the annulment of the first trial decision, taking the case to the second trial.

 

The company may likely file appeals for the other cases that it had not yet appealed to as well.

 

If the first trial decision is reversed in the second trial, the early release of generics by generic companies will be reinterpreted as patent infringement.

 

In this case, Novartis will file claims for damages on the patent infringement to the companies.

 

In line with this, the generic companies need to overcome the patent infringement suit and the injunction application filed by Novartis to the Seoul Central District Court and others.

 

Novartis filed a suit against the generic companies for infringing Entresto’s patent, and also filed an injunction requesting that the release of generics be banned until the results are made.

 

The results of the injunction application are yet to be released.

 

On the generic companies’ part, Novartis’s remaining non-listed and newly listed patents remain a burden.

 

In the case of Entresto, 2 other patents remain in addition to the 4 patents that generic companies have now overcome.

 

One of the 2 remaining patents is a salt·hydrate patent that was not listed in the patent register.

 

This patent is set to expire in November 2026.

 

Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and Elyson Pharm have challenged the patent, and a ruling has not been made yet.

 

The other patent is a newly listed use patent that was registered after the generic companies applied for marketing authorization.

 

The new patent will expire in August 2033, and no company has yet challenged the patent.

 

The generic companies can release their generics without avoiding or invalidating the two patents.

 

The two remaining patents will not affect the companies’ acquisition of first generic exclusivity.

 

However, there is the possibility that the court may make a patent infringement judgment apart from the Intellectual Property Trial and Appeal Board’s ruling based on those two patents.

 

From the generic companies’ point of view, the companies cannot rule out the concern over compensation for damages that may arise from this patent infringement.

 

An industry official said, “Entresto is protected with several layers of patents, and generic companies have to bear the burden of overcoming all the patents; On the other hand, Novartis can prevent the early release of its generics even if it wins only one of all of its disputes.” Entresto’s ongoing patent dispute is the largest single product lawsuit in progress in the Korean pharmaceutical industry.

 

20 Korean companies have filed trials to confirm the passive scope of rights and patent invalidation trials on 4 patents.

 

Novartis countered the suits by filing patent infringement and injunction applications to the Seoul Central District Court.

 

The number of trials and litigations related to Entresto patents that have been filed with the Intellectual Property Trial and Appeal Board, the Patent Court of Korea, and the Seoul Central District Court has reached 130.